510(k) Report

FDA product code · Ophthalmic

Spectacle Microscope, Low-Vision

HKCClass I21 CFR 886.5540510(k) exempt1 decision since 19830 recalls

FDA lists HKC as exempt from 510(k): a device of this type needs no clearance unless one of the limits in 21 CFR 886.9 applies, such as a new intended use or a different fundamental technology. 1 FDA decision since 1983. No recall names this code.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026 Download the data (CSV)

FIG. A — Illustration, ophthalmic panel

Twenty years of HKC at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.

FDA decisions per year · HKC

FDA has decided no HKC device since 2007.

Median 510(k) review, days · HKC

Too few HKC 510(k)s in any year since 2007 to give a median.

Recalls per year · HKC

No recall names HKC since 2007.

Adverse event reports per year · HKC

No MAUDE report names HKC since 2007.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—
FIG. 1 — HKC by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in HKC? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

What has FDA decided in HKC lately?

  • K830774Binocular Magnifier 2XAlmore Intl., Inc. · 1983

The one HKC decision →

Related product codes

Other codes under 21 CFR 886.5540.

HJF Magnifier, Hand-Held, Low-Vision